job_040411a: Director of Mfg Loma Vista Medical (Burlingame, CA)

From: Kristin Burns <kristin.burns_at_stanford.edu>
Date: Mon, 04 Apr 2011 10:19:22 -0700

TITLE: Director of Manufacturing

SUMMARY
Loma Vista Medical (LVM) designs and manufactures
the world’s most advanced composite medical
inflatables. We are based in Burlingame,
California. We are seeking a high performance
individual who can manage and lead our
manufacturing operations. The desired individual
will possess a broad range of experience in the
medical device field, including knowledge of
disposable medical device design and
manufacturing, and familiarity with all
applicable Quality Assurance requirements,
including ISO and QSR requirements. The ideal
candidate would display the ability to perform to
the below requirements, would show a high level
of individual responsibility, and would act with
passion and intensity in a VC-funded medical
device start-up that is fast-paced and collaborative.


JOB DUTIES AND RESPONSIBILITIES
    * Manage the resources of the manufacturing
group to ensure efficient utilization of staff in a dynamic environment.
    * Plan and implement elements of FDA QSR and
ISO 13485 medical device regulations.
    * Work closely with manufacturing staff to
ensure adherence to all quality assurance
procedures and requirements and to ensure that
products meet reliability, and quality
expectations for invasive medical devices.
    * Plan production schedules for current and next-generation product.
    * Identify and incorporate new technology and
methods into LVM’s capabilities.
    * Ensure that staff are recruited, selected
and sufficiently trained to meet current and future work requirements.
    * Work with staff in administering the
performance management system to ensure
development needs are met and feedback is provided on a regular basis.
    * Ensure the proper application of Human
Resource policies through recommendation and
approval of Human Resource actions such as salary
administration, disciplinary action, and paid time off.
    * Organize the coordination of activities
with outside suppliers and consultants to ensure timely delivery.
    * Interact with client companies in a
professional manner. Proactively communicate with
client companies to ensure an ongoing two-way exchange of information.
    * Be able to project manage, as well as
provide hands-on during manufacturing transfer.
· Assist in the development of novel concepts
that lead to an enhanced intellectual property portfolio.
· Designing on CAD and then following thru to
manufacture, utilization & characterization,
next-generation manufacturing equipment.
· Develop test methods, protocols, reports
and conclusions to evaluate components, processes and assemblies.
· Create manufacturing documentation,
including Manufacturing Process Instructions, Bills of Materials and Travelers.
· Specify and modify manufacturing equipment.


ESSENTIAL REQUIREMENTS
· B.S. or M.S. in Mechanical
Engineering. Related degrees are acceptable but
you should be able to convince us that you are
very competent in the role of a manufacturing engineer & manager.
· 8+ years of work experience as a manufacturing engineer.
    * 5+ years of work experience in medical device manufacturing.
    * 5+ yeas of work experience as a manager.
    * Experience with medical device quality
systems, V+V studies and regulatory filings.
· Experience creating and managing
schedules, budgets, and plans. Give us examples!
    * Experience as a pivotal part of a team that
developed products from invention to scaled market release. Give us examples!
· A willingness to work hard, with a
driven outlook and with a strong desire to
succeed as an individual, as a manager, as a
leader, and as a key part of the company.
    * An inventive aptitude, balanced with discipline and detail-orientation.

HIGHLY DESIRABLE SKILLS
    * Expertise in the area of catheters is highly desirable.
    * Experience in a start-up environment
wearing multiple hats. What is the best part of
start-ups for you? What is the worst?
    * Strong clinical background with a thorough
knowledge of anatomy & disease, exposure to
doctors, and surgical procedure development. Do
your current professional contacts include MDs?
    * Proficient with Solidworks.

PLEASE SEND US
· A short cover letter showing us that
you have read this ad and are responding to our
needs. This really matters! Tell us, briefly, why
you could be great in this role.
· Your resume.
· Ideally, some samples of your work.
This could be a link to a website, a portfolio in
PDF or word, some JPGs or whatever you think can
give us a sense for what you have done.
· Send to:
<mailto:alex_at_lomavistamedical.com>alex (at) lomavistamedical.com
Received on 2011-04-04 10:18:54